Prosthetic Heart Valve Leaflet Slack for Compression Delivery

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Solution Overview

Problem

Existing prosthetic heart valves experience leaflet deformation and damage due to axial overstretching during radial compression for delivery, which can compromise their functionality.

Innovation Solution

A prosthetic heart valve design featuring an annular frame that radially compresses and expands, with leaflets coupled to the frame such that they have slack in an axial direction in a partially compressed state, reducing axial stretching and minimizing damage during compression.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the frame is radially compressed for delivery, then the valve can be delivered through patient vasculature, but the leaflets experience axial overstretching which deforms and damages them

Engineering Contradiction:

ImprovedeliverabilityVSAvoidleaflet integrity

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent applies the dynamics principle by making the attachment between leaflets and frame adjustable rather than fixed. The attachment mechanism allows varying degrees of movement between the leaflet and frame, enabling the system to adapt dynamically during compression and expansion. This dynamic attachment prevents excessive stress transmission to the leaflets during radial compression while maintaining proper leaflet function during expansion.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent applies parameter changes by modifying the attachment characteristics between leaflets and frame. The attachment mechanism changes its mechanical properties based on the operational state, providing different levels of constraint during compression versus expansion. This parameter adjustment allows the system to protect leaflets from overstretching during delivery while ensuring proper function during operation.

Inventive Principle:

Principle #35Parameter changes

2Volume of moving object

If the frame elongates axially when radially compressed, then the valve can be compressed for delivery, but this causes overstretching of the leaflets in the axial direction

Engineering Contradiction:

Improvecompressed volumeVSAvoidleaflet strength

Core Design Contradiction:

Volume of moving objectVSStrength

Solution Approach 1:

The patent applies beforehand cushioning by incorporating a protective attachment mechanism that anticipates and prevents excessive stress on the leaflets before compression occurs. The attachment mechanism is designed in advance to absorb and distribute compressive forces, cushioning the leaflets from the full impact of axial overstretching that would otherwise occur during radial compression for delivery.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The patent applies the intermediary principle by introducing an intermediate attachment mechanism between the leaflets and the frame. This intermediary component decouples the direct mechanical connection, allowing the frame to compress and elongate while the intermediary attachment protects the leaflets from experiencing the full extent of axial overstretching. The intermediary acts as a buffer that mediates the force transmission during compression.

Inventive Principle:

Principle #24Intermediary (Mediator)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The design maintains leaflet integrity by allowing them to remain in a relaxed state during partial compression, preventing damage and ensuring proper function upon expansion.

Implementation Method 1

an annular frame that is radially compressible and expandable between a radially compressed state and a radially expanded state

Methodology Applied

Scientific EffectRadial compression and expansion:

Implementation Method 2

wherein the frame elongates in an axial direction when radially compressed from the radially expanded state to the radially compressed state

Methodology Applied

Scientific EffectAxial elongation during radial compression:

Implementation Method 3

a plurality of leaflets disposed inside of the frame and configured to permit blood to flow through the frame in a first direction and block the flow of blood in a second direction, opposite the first direction

Methodology Applied

Scientific EffectValve flow control:

Implementation Method 4

The leaflets are coupled to the frame such that when the frame is in the radially expanded state, the leaflets have slack in an axial direction, wherein when the frame is radially compressed to a partially radially compressed state between the radially expanded state and the radially compressed state, the leaflets are in a relaxed state

Methodology Applied

Scientific EffectSlack mechanism reducing axial stretch:

Data Source

PatentEP4087521B1Prosthetic heart valve

Publication Date: 2025.10.29 EDWARDS LIFESCIENCES CORP

Figure 1
Figure 2~3A
Figure 3B~4

AI summary

A prosthetic heart valve comprises an annular frame that is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame elongates in an axial direction when radially compressed from the radially expanded state to the radially compressed state. Leaflets are coupled to the frame such that when the frame is in the radially expanded state, the leaflets have slack in an axial direction, wherein when the frame is radially compressed to a partially radially compressed state between the radially expanded state and the radially compressed state, the leaflets are in a relaxed state, and wherein when the frame is in the radially compressed state, the leaflets are stretched in the axial direction.